Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01294462
First received: February 10, 2011
Last updated: June 18, 2014
Last verified: May 2014
Results First Received: July 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Interventions: Drug: Ticagrelor
Drug: Clopidogrel
Drug: Acetylsalicylic acid ASA

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In total, 817 patients were enrolled from 3 countries (Japan, South Korea and Taiwan). Of the randomised patients, most patients were Japanese (723 [90.3%]). The first patient was enrolled on 28 February 2010 and the last patient completed the study on 31 July 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 801 patients (401 in the ticagrelor [AZD6140 90 mg bd] group and 400 patients in the clopidogrel [clopidogrel 75 mg od] group) were randomised to treatment. The reasons for not being randomised were “Incorrect enrolment before randomisation” and “Patient decision (withdrawal of consent)”.

Reporting Groups
  Description
Ticagrelor (AZD6140) Ticagrelor (AZD6140) 90 mg bid
Clopidogrel Clopidogrel 75mg od

Participant Flow:   Overall Study
    Ticagrelor (AZD6140)     Clopidogrel  
STARTED     401     400  
Received Randomized Treatment     387     380  
COMPLETED     335     337  
NOT COMPLETED     66     63  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 65                 63  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One discontinued patient (due to withdrawal of consent) in Ticagrelor (AZD6140) group did not agree to disclose any data. Thus the number of baseline participants in Ticagrelor (AZD6140) group is 400 instead of 401 that is the number of participants who started the first period.

Reporting Groups
  Description
Ticagrelor (AZD6140) Ticagrelor (AZD6140) 90 mg bid
Clopidogrel Clopidogrel 75mg od
Total Total of all reporting groups

Baseline Measures
    Ticagrelor (AZD6140)     Clopidogrel     Total  
Number of Participants  
[units: participants]
  400     400     800  
Age  
[units: Years]
Mean ± Standard Deviation
  67  ± 12     66  ± 11     67  ± 11  
Gender  
[units: Participants]
     
Female     95     93     188  
Male     305     307     612  
Race/Ethnicity, Customized  
[units: Participants]
     
Chinese     16     19     35  
Japanese     361     360     721  
Korean     23     21     44  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Major Bleeding   [ Time Frame: Ongoing up to12 months ]

2.  Primary:   Major Adverse Cardiac Events (MACE)   [ Time Frame: Ongoing up to 12 months ]

3.  Secondary:   Major and Minor Bleeding   [ Time Frame: Ongoing up to12 months ]

4.  Secondary:   Composite of All-cause Mortality, MI or Stroke   [ Time Frame: Ongoing up to 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Judith Hsia
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01294462     History of Changes
Other Study ID Numbers: D5130C00027
Study First Received: February 10, 2011
Results First Received: July 10, 2013
Last Updated: June 18, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Taiwan: Department of Health